Abstract
Despite advances in regulations and initiatives to increase pediatric medicine development, there is still an unmet need for age-appropriate medicines for children. The availability of pediatric formulations is particularly lacking in resource poor areas, due to, for example, area-specific disease burden and financial constraints, as well as disconnected supply chains and fragmented healthcare systems. The paucity of authorized pediatric medicines often results in the manipulation and administration of products intended for adults, with an increased risk of mis-dosing and adverse reactions. This article provides an overview of the some of the key difficulties associated with the development of pediatric medicines in both high and low resource areas, and highlights shared and location specific challenges and opportunities. The utilization of dispersible oral dosage forms and suppositories for low and middle-income countries (LMICs) are described in addition to other platform technologies that may in the future offer opportunities for future pediatric medicine development for low resource settings.
Highlights
Pediatric patients are defined as patients aged from birth to less than 16 or 18 years, depending on region [1]
The development of flexible solid dosage forms, for example tablets that can be dispersed or dissolved in a beverage prior to administration, have been recommended by World Health Organization (WHO) [44]. They are considered to be suitable for low and middle-income countries (LMICs) because they have some of the advantages of solid oral dosage forms, such as superior stability and less bulk compared to liquids, and once dispersed are acceptable for patients of all ages, including those who have difficulty in swallowing tablets
The development of pediatric medicines has greater challenges compared to the development of medicines intended for adult patients, which has led to a significant unmet medical need
Summary
Pediatric patients are defined as patients aged from birth to less than 16 or 18 years, depending on region [1]. Despite almost one third of the world’s population being less than 18 years old [2], there is a global lack of licensed medicines for pediatric use. This is due to factors such as the diversity in age and therapeutic needs of this patient population leading to greater challenges in conducting research into medicines for pediatrics compared to adult products. Insights into the current situation regarding the formulation and administration of age-appropriate medicines for both high and low resource settings are provided to highlight shared and specific key challenges. Health Organization (WHO) is described [3], as well as suppositories and other platform technologies that may have the potential to provide opportunities for future development in low and middle-income countries (LMICs). (Defined as those with a gross national income per capita of less than $12,375 in 2018, in accordance with the World Bank [4])
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